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2003
251-500
Health Care, Pharmaceutical, Medical
Bio
Amy Wolbeck joined Intersect ENT in January of 2009. She has over 16 years' experience in regulatory and quality for the medical device industry with large corporations as well as small start-up companies. Ms. Wolbeck's experience includes coronary, carotid and peripheral vascular stents, AAA stent graphs, embolic protection devices, drug/biologic delivery systems, combination products and orthopedic implants.
Prior to joining Intersect, Ms. Wolbeck held director positions at Medtronic's Cardiovascular Division as Director of Regulatory Affairs as well as Director of Quality. Ms. Wolbeck was the Director of Regulatory Affairs and Quality Assurance at Sonoma Orthopedic Products and also worked for several years as a consultant providing regulatory and quality expertise to the medical device, biotech and pharmaceutical industries.
Ms. Wolbeck has extensive experience with the design and implementation of Quality Systems and for bringing Class I/II/III Medical Devices to market, including Class III combination product implants.
Ms. Wolbeck holds a B.S. in Mechanical Engineering from the University of Massachusetts at Amherst.
Location
Santa Rosa, California, United States, North America
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University of Massachusetts
Mechanical Engineering
Profile Resume
Amy Couel Wolbeck is the Vice President, Regulatory Affairs and Quality at Intersect ENT, based in United States, North America. With a background in Health Care, Amy Couel Wolbeck has a rich history of leadership and innovation.Amy Couel Wolbeck studied BS Mechanical Engineering at University of Massachusetts. Explore their detailed professional journey, key connections, and contributions to the industry on our platform.
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